Regulatory Compliance Solutions

  1. FDA 21 CFR Part 11-Compliant Software 2/28/2023

    Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

    Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

  2. Electronic Batch Records (EBR) Software For Drug Manufacturing 10/23/2024

    Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.

  3. Pharmaceutical Operational Readiness Programs 10/24/2024

    Many Life Sciences companies struggle to minimize downtime, ensure safe operations, and reach tight production schedules while maintaining consistent, quality output in a demanding environment, but you can boost efficiency and reliability through our field-tested methodologies.

  4. Simplify Microplate Data Acquisition And Analysis With SoftMax Pro Software 6/21/2023

    SoftMax® Pro Software - The most published microplate reader control and data analysis software

    Preconfigured protocols and custom assay workflows simplify microplate data acquisition and analysis

    SoftMax® Pro Software for Windows 10 is designed to provide the simplicity, flexibility and power required for advanced data analysis. It provides ready-to-run protocols, analysis algorithms, and 21 different curve fit options. Every step is optimized for data acquired from a Molecular Devices microplate reader or data imported from another source to simplify analysis and reporting. Compliance tools are available for regulated laboratories providing end-to-end chain of custody.

  5. Annex 1-Compliant Real-Time Viable Particle Counter 12/15/2022

    What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.

  6. Build A Skilled Workforce With Operator Training Programs 5/29/2025

    Human error is the leading cause of poor outcomes after equipment failure in biopharma. Learn how self-paced training, 3D models, and VR simulations can boost operator confidence and process reliability.

  7. HyClone™ Cell Culture Media For Viral Vector Production 11/6/2025

    Whether you're looking to boost performance, enhance your capabilities, or simply get consistent, high-quality results, HyClone™ peak expression medium and HyClone™ prime expression medium are the solutions for you.

  8. Regulated Document Review 3/24/2025

    Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.

  9. R&D And Analytical Services 3/4/2022

    Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.

  10. Pharmaceutical Metal Detector 12/29/2025

    Meet FDA guidelines for GMP in tablet and capsule production with a secure, failsafe system. Qualification reports are available.